VIsualization of Coronary Artery Disease for Modification of RISK Factors

Last updated: February 17, 2025
Sponsor: Aarhus University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Atherosclerosis

Chest Pain

Treatment

Follow up at general practice

Visualization of CTA images

Follow up at GP

Clinical Study ID

NCT06413641
NNF21OC0068200
1-10-72-213-22
  • Ages > 18
  • All Genders

Study Summary

The VICAD-RISK study assesses if visualization of coronary CT angiography (CTA) images in participants with non-obstructive coronary artery disease will improve LDL lowering, reduce reporting of side effects by cholesterol lowering medications, and modify the coronary artery disease phenotype over 12 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New diagnosis of nonobstructive coronary artery disease

  • No known coronary artery disease (no previous coronary revascularization)

  • CAD-Rads score 1-3

  • LDL cholesterol > 2.0 mmol/l

  • Life expectancy >3 years

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Post CTA test indication for invasive coronary angiography

  • Non-evaluable CTA exam

  • Obstructive coronary disease (One or more coronary stenosis ≥70%, left main >40%)

  • Ongoing lipid lowering medical treatment (Patients already on lipid lowering medicaltherapy can be included if the treatment was initiated <3 months before the time ofthe CTA test)

  • BMI >40

  • Renal insufficiency (eGFR <40 ml/min)

  • Allergy to iodinated contrast media

  • Contraindications to statins (Active liver disease Child-Pugh A, B and C, excessivealcohol consumption)

  • Participation in a cardiac rehabilitation or lifestyle modification program

  • Pregnancy

Study Design

Total Participants: 273
Treatment Group(s): 4
Primary Treatment: Follow up at general practice
Phase:
Study Start date:
March 12, 2024
Estimated Completion Date:
August 31, 2026

Study Description

In Denmark non-obstructive coronary artery disease is found in 35-40% of patients undergoing coronary CT angiography for suspected coronary artery disease. Modification of risk factors is essential in patients with coronary artery disease to prevent major cardiovascular events. However, in non-obstructive coronary artery disease, initiation and adherence to treatment with lipid lowering therapy is poor.

The study will include 273 patients from 5 different sites; patients will be randomized into 3 groups; standard follow up by general practice, structured disease education or the combination of the latter with visualization of coronary CT angiography images. A follow-up CT angiography will be performed at 12 months.

Connect with a study center

  • Gødstrup Hospital

    Gødstrup, Jutland
    Denmark

    Active - Recruiting

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Bjarne L Nørgaard

    Aarhus,
    Denmark

    Active - Recruiting

  • Hospital of South West Jutland

    Esbjerg,
    Denmark

    Active - Recruiting

  • Vejle Hospital

    Vejle, 7100
    Denmark

    Active - Recruiting

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